Case 2:33-av-00001 Document 14716 Filed 04/20/12 Page 1 of 11 PageID: 287858

David E. De Lorenzi Todd M. Nosher GIBBONS P.C. One Gateway Center Newark, New Jersey 017102-5310 Telephone: (973) 596-4629 Facsimile: (973) 639-8379 ddelorenzi@gibbonslaw.com Leora Ben-Ami Benjamin C. Hsing KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022-3598 (212) 836-8000 Attorneys for Plaintiffs OSI Pharmaceuticals, LLC Pfizer Inc., and Genentech, Inc.

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY ) ) ) ) ) ) ) ) ) ) ) ) )

OSI PHARMACEUTICALS, LLC, PFIZER, INC., and GENENTECH, INC., Plaintiffs, v. ROXANE LABORATORIES, INC., Defendant.

Civil Action No.:_________ DOCUMENT FILED ELECTRONICALLY

COMPLAINT

Plaintiffs OSI Pharmaceuticals, LLC (OSI), Pfizer Inc. (Pfizer), and Genentech, Inc. (Genentech), by their undersigned attorneys, bring this action against Defendant, Roxane Laboratories, Inc. (Roxane), for patent infringement and allege as follows:

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Nature of the Action 1. This is an action for patent infringement under the patent laws of the United

States, Title 35 of the United States Code, arising from Roxanes filing an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking approval to commercially market a generic version of TARCEVA prior to the expiration of certain patents that cover that product or its use; United States Reissued Patent No. RE 41,065 (the RE 065 patent), United States Patent No. 6,900,221 (the 221 patent), and United States Patent No. 7,087,613 (the 613 patent). Proceeding in the U.S. District Court for the District of Delaware 2. Plaintiffs have previously filed a suit on April 13, 2012 in the U.S. District

Court for the District of Delaware (OSI Pharmaceuticals, LLC, et al. v. Roxane Laboratories, Inc., Civil Action No. 1:12-cv-00465) against Roxane, asserting infringement of the same three patents that are the subject of this suit (the Delaware action). The Delaware action is proceeding. It has been assigned to Judge Sue L. Robinson, and Roxane has been served with the complaint, summons, and related papers. Judge Robinson presided over a case involving the patents asserted in this suit and presided over a bench trial in that case in March of 2011. (See OSI Pharmaceuticals, Inc., et al. v. Teva Pharmaceuticals USA, Inc., et al., Civil Action No. 09185.) 3. On information and belief, the Court in the District of Delaware has jurisdiction

over Roxane, and, accordingly, that earlier-filed action in that proceeding should proceed. Roxane already has been served in the Delaware action. However, out of an abundance of caution, in the highly unlikely event that Roxane prevails in any challenge to the jurisdiction of the Delaware court over Roxane, Plaintiffs are filing the instant suit in this jurisdiction. 2

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The Parties 4. Plaintiff OSI is a limited liability company organized and existing under the

laws of the State of Delaware, with a principal place of business at 1 Bioscience Park Drive Farmingdale, New York 11735. 5. Plaintiff Pfizer is a corporation organized and existing under the laws of the

State of Delaware, with a principal place of business located at 235 East 42nd Street, New York, New York 10017. 6. Plaintiff Genentech is a corporation organized and existing under the laws of

the State of Delaware, with a principal place of business located at 1 DNA Way, South San Francisco, California 94080-4990. 7. On information and belief, Defendant Roxane is a corporation organized and

existing under the laws of the State of Nevada, with a principal place of business at 1809 Wilson Road, Columbus, Ohio 43228. Jurisdiction and Venue 8. This Court has jurisdiction over the subject matter of this action pursuant to 28

U.S.C. 1331, 1338(a) and 2201-2202. 9. On information and belief, Roxane markets and sells pharmaceutical products

throughout the United States, including the State of New Jersey, and Roxane derives substantial revenue from New Jersey drug sales. 10. On information and belief, Roxane is registered to do business in New Jersey

and the Corporation Trust Company, 820 Bear Tavern Road, Ewing, New Jersey 08628, is its registered agent in New Jersey.

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11.

On information and belief, Roxane has previously consented to personal

jurisdiction and filed counterclaims in this judicial district in several cases. 12. On information and belief, this court has personal jurisdiction over Roxane by

virtue of, inter alia, its having conducted businesses in New Jersey, having availed itself of the rights and benefits of New Jersey, and having engaged in systematic and continuous contact with the State of New Jersey. 13. Venue is proper in this District pursuant to 28 U.S.C. 1391 and 1400(b). The Patents in Suit 14. On May 5, 1998, the United States Patent and Trademark Office (USPTO)

duly and lawfully issued U.S. Patent No. 5,747,498 (the 498 patent), entitled Alkynyl and Azido-Substituted 4-Anilinoquinazolines to inventors Rodney Caughren Schnur and Lee Daniel Arnold. 15. On February 27, 2008, OSI and Pfizer filed with the USPTO an application,

Serial No. 12/038,530, for reissue of the 498 patent. On December 29, 2009, the USPTO duly and lawfully reissued the 498 patent as the RE 065, entitled Alkynyl and Azido-Substituted 4Anilinoquinazolines to inventors Rodney Caughren Schnur and Lee Daniel Arnold. A copy of the RE 065 patent is attached hereto as Exhibit A. 16. OSI and Pfizer are owners of the RE 065 patent and Genentech is a co-

exclusive licensee of the RE 065 patent. 17. On May 31, 2005, the USPTO duly and lawfully issued the 221 patent, entitled

Stable Polymorph on N-(3-Ethynylphenyl)-6, 7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride, Methods of Production, and Pharmaceutical Uses Thereof to inventors Timothy

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Norris, Jeffrey W. Raggon, Richard D. Connell, James D. Moyer, Michael J. Morin, Shama M. Kajiji, Barbara A. Foster, Karen J. Ferrante, and Sandra L. Silberman. A copy of the 221 patent is attached hereto as Exhibit B. 18. the 221 patent. 19. On August 8, 2006, the USPTO duly and lawfully issued the 613 patent, OSI is the owner of the 221 patent and Genentech is a co-exclusive licensee of

entitled Treating Abnormal Cell Growth With A Stable Polymorph on N-(3-Ethynylphenyl)-6, 7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride to inventors Timothy Norris, Jeffrey W. Raggon, Richard D. Connell, James D. Moyer, Michael J. Morin, Shama M. Kajiji, Barbara A. Foster, Karen J. Ferrante, and Sandra L. Silberman. A copy of the 613 patent is attached hereto as Exhibit C. 20. the 613 patent. The TARCEVA Drug Product 21. OSI holds an approved New Drug Application (NDA) under Section 505(a) OSI is the owner of the 613 patent and Genentech is a co-exclusive licensee of

of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 355(a) for erlotinib hydrochloride tablets (NDA No. 021743), which OSI and Genentech market and sell under the trade name TARCEVA. The claims of the RE 065, 221 and 613 patents cover, inter alia, TARCEVA and its methods of use. 22. Pursuant to 21 U.S.C. 355(b)(1) and attendant FDA regulations, the RE 065,

221, and 613 patents are listed in the FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book), with respect to TARCEVA.

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Acts Giving Rise to This Suit 23. Pursuant to Section 505 of the FFDCA, Roxane filed an ANDA for erlotinib

hydrochloride tablets, seeking approval to engage in the commercial use, manufacture, sale, offer for sale or importation of erlotinib hydrochloride tablets 150 mg (Roxanes Proposed Product), before the patents in suit expire. The Roxane ANDA number is 203-843. 24. In connection with the filing of its ANDA as described in the preceding

paragraph, Roxane has provided written certification to the FDA, as called for by Section 505 of the FFDCA, which alleges that the claims of the RE 065, 221, and 613 patents are not infringed and/or are invalid. 25. No earlier than March 6, 2012, Roxane sent written notice of its ANDA filing

to OSI and Pfizer. The notice alleged that the RE 065, 221, and 613 patents are not infringed and/or are invalid. Roxanes notice also informed OSI and Pfizer that Roxane seeks approval to market erlotinib hydrochloride tablets 150 mg before the patents in suit expire. 26. This action is being brought pursuant to 21 U.S.C. 355(j)(5)(B)(iii) within 45

days of OSI and Pfizers receipt of Roxanes notice. Count I: Infringement of the RE 065 Patent 27. set forth herein. 28. Roxanes submission of its ANDA to obtain approval to engage in the Plaintiffs repeat and reallege the allegations of paragraphs 1-26 as though fully

commercial manufacture, use, sale, offer for sale or importation of Roxanes Proposed Product, prior to the expiration of the RE 065 patent, constitutes infringement of one or more of the claims of that patent under 35 U.S.C. 271(e)(2)(A).

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29.

Unless enjoined by this Court, Roxane, upon FDA approval of Roxanes

ANDA, will infringe the RE 065 patent by making, using, offering to sell, importing, and selling Roxanes Proposed Product in the United States, and by actively inducing and contributing to infringement by others. 30. There is a justiciable controversy between the parties hereto as to infringement

of the RE 065 patent. 31. Plaintiffs will be substantially and irreparably damaged and harmed if Roxanes

infringement of the RE 065 patent is not enjoined. 32. 33. Plaintiffs do not have an adequate remedy at law. This case is an exceptional one, and Plaintiffs are entitled to an award of their

reasonable attorneys fees under 35 U.S.C. 285. Count II: Infringement of the 221 Patent 34. set forth herein. 35. Roxanes submission of its ANDA to obtain approval to engage in the Plaintiffs repeat and reallege the allegations of paragraphs 1-33 as though fully

commercial manufacture, use, sale, offer for sale or importation of Roxanes Proposed Product, prior to the expiration of the 221 patent, constitutes infringement of one or more of the claims of that patent under 35 U.S.C. 271(e)(2)(A).

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36.

Unless enjoined by this Court, Roxane, upon FDA approval of Roxanes

ANDA, will infringe the 221 patent by making, using, offering to sell, importing, and selling Roxanes Proposed Product in the United States, and by actively inducing and contributing to infringement by others. 37. There is a justiciable controversy between the parties hereto as to infringement

of the 221 patent. 38. Plaintiffs will be substantially and irreparably damaged and harmed if Roxanes

infringement of the 221 patent is not enjoined. 39. 40. Plaintiffs do not have an adequate remedy at law. This case is an exceptional one, and Plaintiffs are entitled to an award of their

reasonable attorneys fees under 35 U.S.C. 285. Count III: Infringement of the 613 Patent 41. set forth herein. 42. Roxanes submission of its ANDA to obtain approval to engage in the Plaintiffs repeat and reallege the allegations of paragraphs 1-40 as though fully

commercial manufacture, use, sale, offer for sale or importation of Roxanes Proposed Product, prior to the expiration of the 613 patent, constitutes infringement of one or more of the claims of that patent under 35 U.S.C. 271(e)(2)(A). 43. Unless enjoined by this Court, Roxane, upon FDA approval of Roxanes

ANDA, will infringe the 613 patent by making, using, offering to sell, importing, and selling

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Roxanes Proposed Product in the United States, and by actively inducing and contributing to infringement by others. 44. There is a justiciable controversy between the parties hereto as to infringement

of the 613 patent. 45. Plaintiffs will be substantially and irreparably damaged and harmed if Roxanes

infringement of the 613 patent is not enjoined. 46. 47. Plaintiffs do not have an adequate remedy at law. This case is an exceptional one, and Plaintiffs are entitled to an award of their

reasonable attorneys fees under 35 U.S.C. 285. PRAYER FOR RELIEF WHEREFORE, Plaintiffs OSI, Pfizer, and Genentech respectfully request the following relief: (A) A judgment declaring that Defendant has infringed the RE 065, 221, and 613

patents by submitting the aforementioned ANDA, and that Defendants making, using, selling, offering to sell, or importing of Roxanes Proposed Product will infringe the RE 065, 221, and 613 patents; (B) A judgment ordering that the effective date of FDA approval of Defendants

ANDA be a date which is not earlier than the latest of the expiration of the RE 065, 221, and 613 patents, or any later expiration of exclusivity to which Plaintiffs are or become entitled; (C) A judgment permanently enjoining Defendant and its officers, agents, attorneys

and employees, and those acting in privity or concert with them, from making, using, selling,

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offering to sell, or importing Roxanes Proposed Product until after the expiration of the RE 065, 221, and 613 patents, or any later expiration of exclusivity to which Plaintiffs are or become entitled; (D) If Defendant engages in the commercial manufacture, use, importation into the

United States, sale, or offer for sale of Roxanes Proposed Product prior to the expiration of the RE 065, 221, and 613 patents or any later expiration of exclusivity to which Plaintiffs are or become entitled, a judgment awarding damages to Plaintiffs resulting from such infringement, together with interest; (E) (F) (G) Attorneys fees in this action as an exceptional case pursuant to 35 U.S.C. 285; Costs and expenses in this action; and Such further and other relief as this Court may deem just and proper.

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Dated: April 20, 2012

s/ David E. De Lorenzi David E. De Lorenzi Todd M. Nosher GIBBONS P.C. One Gateway Center Newark, New Jersey 017102-5310 Telephone: (973) 596-4629 Facsimile: (973) 639-8379 ddelorenzi@gibbonslaw.com

Leora Ben-Ami Benjamin C. Hsing KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022-3598 (212) 836-8000 Attorneys for Plaintiffs OSI Pharmaceuticals, LLC Pfizer Inc., and Genentech, Inc.

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